Iron Metabolism in Cystic Fibrosis

Prevalence and Incidence of Iron Deficiency in Cystic Fibrosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04584489

Enrollment

100

Registered

2020-10-14

Start date

2020-02-01

Completion date

2021-02-01

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Metabolism, Cystic Fibrosis

Brief summary

Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function. Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold \< 30 µg/L). Previously published studies used less performant markers such as serum iron (\< 12 µmol/L) or transferrin saturation (\< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation. The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.

Interventions

OTHERiron stores assessment.

assessment of iron stores by measuring serum ferritin level (mandatory), serum iron and transferrin saturation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cystic fibrosis genetically proven. * Age ≥ 18 years * Systematic annual follow-up.

Exclusion criteria

* Dietary or drugs iron supplements * Systemic inflammation or pulmonary exacerbation * Lung transplantation

Design outcomes

Primary

Measure	Time frame	Description
prevalence of iron deficiency defined by serum ferritin ≤ 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).	1 year	from inclusion to first documented up to 1 year

Countries

France

Contacts

Primary ContactQuitterie REYNAUD, MD

mailto:quitterie.reynaud@chu-lyon.fr00334 78 56 91 05

Backup ContactHerve LOBBES, MD

mailto:herve.lobbes@chu-lyon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026